Trial Information

OBJECTIVES: I. Compare time to disease progression in patients receiving THERATOPE vaccine
to that of women receiving control vaccine. II. Compare survival in patients receiving
THERATOPE vaccine to that of patients receiving control vaccine. III. Document the product
safety profile in these patients. IV. Measure the anti-STn, anti-OSM, and anti-KLH antibody
titers. V. Evaluate the impact of THERATOPE STn-KLH vaccine on health-related quality of
life in these patients.

OUTLINE: The study design is a prospective, double-blinded, randomized study. Patients who
have completed first-line chemotherapy for metastatic breast cancer and have either
nonprogressive disease or no evidence of disease following completion of first-line
chemotherapy (includes bone marrow transplants and stem cell rescue) will be randomized to
either the THERATOPE vaccine or the control vaccine. Patients are stratified at entry
according to disease status (i.e., either no evidence of disease or nonprogressive disease)
and whether or not they are receiving hormonal therapy for metastatic disease while on
study. Arm I: Patients receive intravenous cyclophosphamide on day -3, followed by 4
subcutaneous vaccinations with THERATOPE STn-KLH vaccine combined with Detox-B Stable
Emulsion at 0, 2, 5, and 9 weeks. Arm II: Patients receive the control treatment of
intravenous cyclophosphamide on day -3, followed by 4 subcutaneous vaccinations with keyhole
limpet hemocyanin (KLH) vaccine combined with Detox-B Stable Emulsion at 0, 2, 5, and 9
weeks. Patients with stable or responding disease may receive the THERATOPE STn-KLH vaccine
or control without Detox-B Stable Emulsion at weeks 13, 17, 21, and 25. Patients without
unacceptable toxic effects or disease progression may continue on maintenance therapy at 3
month intervals.

PROJECTED ACCRUAL: Over 120 sites in North America, Europe, and Australia/New Zealand will
be participating in the study. A total of 950 women (475 per treatment arm) will be enrolled
into the study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven breast cancer Must be
enrolled no later than 40 weeks from the start of first line chemotherapy for metastatic
disease High dose chemotherapy with bone marrow transplantation or stem cell rescue as
part of first line therapy is allowed Either no evidence of disease or nonprogressive
disease following first line chemotherapy Patients receiving concurrent hormonal therapy
are eligible Patients with bone metastases as the only site of disease are eligible No
known brain metastases (patients with stable brain metastases for greater than 6 months
may be allowed if not on concurrent corticosteroids) No locoregional disease as the only
evidence of metastases Hormone receptor status: Not specified

NCT ID:

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